Airless intravenous bag

ABSTRACT

The present disclosure provides for an airless intravenous (IV) bag which contains a specialized device, referred to herein as the airless intravasculature infusion device (AIVID). The AIVID allows one to view the amount of fluid in the IV bag but substantially decreases or completely prohibits the risk of an inadvertent air infusion into a patient.

CLAIM TO DOMESTIC PRIORITY

This application claims priority to and the benefit of the filing dateof U.S. Provisional Patent Application No. 61/062,751, filed Jan. 30,2008, entitled “Airless Intravenous Bag,” which application is herebyincorporated in its entirety.

FIELD OF THE INVENTION

The present invention relates to the field of intravenous bag systems,and more particularly, to an airless intravenous bag system thateliminates the need for priming the intravenous line when exchangingintravenous bags.

BACKGROUND

In conventional intravenous bag systems when the bags are totallydepleted (i.e. “run dry”), the previously placed air then is allowed toleave the bag. This usually then fills the drip chamber and the plastictubing of the intravenous line. This can be problematic in manysettings.

Once the tubing has air inside of it, a new bag must be hung, the tubingtransferred to it, and the line must be re-primed. Re-priming involvesplacing a syringe and needle into a port on the intravenous tubing andwithdrawing the air from the tubing. This takes time that can beproblematic when the patient needs intravenous medications or acutefluid administration for a sudden change in their vital signs (i.e.blood pressure, heart rate, etc.). In fact, these intravenous bagsusually are not noticed “running dry” during emergencies becauseeveryone's attention is usually focused on other things. During trueemergent traumas, a patient may be getting intravenous solution morerapidly then with the standard gravity drip. Often times the intravenousbags are placed in pressurized bags or machines that literally squeezethe bag forcing the solution into the patient via the intravenoustubing. Unfortunately, when all the fluid is pressurized out of the bag,the entrapped air is next forced through the intravenous tubing,potentially into the patient.

Air in the intravenous tubing is potentially disastrous because enoughair may cause a “vapor-lock” phenomena whereby the right ventricle ofthe heart fills with air. Normal contractions are ineffective to pushblood through the pulmonary vasculature where it is oxygenated anddelivered to the left ventricle to be pushed out and circulated into thebody. In other words, vapor-lock is a sudden cardiovascular collapsewhere no more blood can be circulated. An adult would need a high amountof air but a pediatric patient with a smaller heart would require muchless air to cause this fatal scenario. Another potential problem is thatair may not collect in the right ventricle, but may get pushed into thepulmonary vasculature. The name for this potentially lethal event iscalled pulmonary embolism. Air may get stuck in the pulmonarycapillaries. This causes an increased resistance to the normal forwardflow to the left atrium of blood. This increased resistance may causethe right side of the heart to fail, also since blood is not beingcirculated, the oxygen content falls, and since it is not getting to theleft side of the heart, the output from the heart into the body drops tocritical levels.

The above two scenarios are certainly possible but require large amountsof air. The most likely scenario for air entering into the vasculatureand causing a devastating complication is via a probe patent or even anopen Foramen Ovale. Bile Foramen Ovale is a unique fetal adaptation thehuman heart has while the fetus in the uterus. Blood is shunted awayfrom the lungs (since the fetus is not breathing) and into the mainvasculature. One way this blood is shunted past the lungs in through ahole in the septum between the right and left atrium of the heart. Thishole is called the Foramen Ovale. Normally this hole closes right alterbirth as the human heart now directs blood into the lungs than pastthem.

Unfortunately, in up to 15% of adults and a much higher correspondinglevel of neonates and children, this percentage is even higher. Probepatent means that a probe can be pushed through the Foramen Ovale whichis only partially closed, or in other situations, it might be completelyopen. If a small air bubble makes it to the right atrium, the normalmechanism of passing into the right ventricle and then getting lodgedinto the palmary vasculature is bypassed. Instead, this air bubble maypass through the Foramen Ovale into the left atrium (bypassing thelungs), entering into the left ventricle, and then squeezed out into thebody. If this air bubble goes to the brain, a devastating stroke mayensue. Central lines, which are long catheters intravenously placed intolarge veins and threaded close to the heart are more likely to causethis situation, however, even a small peripheral intravenous line canstill elicit this situation especially in the setting of a smallpediatric patient.

The above reasons are why medical practitioners are so adamant on notallowing any air to pass into the patient. Unfortunately, with thecurrent intravenous bags that are in use today, this is a constantthreat.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings.

FIG. 1 is a front view of an airless intravenous bag according to oneembodiment of the disclosure.

FIG. 2 is a further illustration of the airless intravenous bagaccording to one embodiment of the disclosure.

FIGS. 3 and 4 are further illustrations of the second chamber of theairless intravenous bag according to one embodiment of the disclosure.

FIG. 5 is a front view of the airless intravenous bag in the openposition.

FIG. 6 is a front view of the airless intravenous bag in the closedposition.

FIG. 7 is a further illustration of the airless intravenous bag in theopen position.

FIG. 8 is a further illustration of the airless intravenous bag in theclosed position.

FIG. 9 is a front view of the airless intravenous bag shown filled withI.V. solution.

FIG. 10 is a further illustration of the airless intravenous bag shownfilled with I.V. solution.

DETAILED DESCRIPTION OF THE FIGURES

The present disclosure provides for an airless intravenous (IV) bagwhich contains a specialized device, referred to herein as the airlessintravasculature infusion device (AIVID). The AIVID allows one to viewthe amount of fluid in the IV bag and substantially decrease orcompletely prohibit the risk of an inadvertent air infusion.

In the following description, numerous specific details are set forth inorder to provide a thorough understanding of the present invention. Itwill be obvious, however, to one skilled in the art that the presentinvention may be practiced without these specific details. In otherinstances, well-known aspects of intravenous bag systems have not beendescribed in particular detail in order to avoid unnecessarily obscuringthe present invention.

As shown in FIG. 1, the disclosed airless intravenous bag 10 comprises astandard pliable plastic IV bag that is divided into two asymmetricalcompartments along its vertical axis the larger of the two compartments,referred to herein as the IV solution compartment 12 holds the IVsolution to be infused into the patient devoid of any air. IV solutioncompartment 12 is comprised of a pliable plastic bag. The second,smaller compartment is air chamber 14.

As shown in further detail in FIG. 2, air chamber 14 is comprised of twoparts, air reservoir 16 and air column 18. The air reservoir 16 isseparated from the IV solution compartment 12 by horizontal seam 20. Airreservoir 18 is also comprised of the same pliable plastic material asIV solution compartment 12. Air column 18 is comprised of a hard plasticcolumn separated from IV solution compartment 12 by vertical seam 22.Air column 18 also comprises a mesh network 24 at the top of air column18, and between air reservoir 16 and air column 18. Air column 18terminates into funnel aperture 26.

Surrounding funnel aperture 26 is airless intravasculature infusiondevice (AIVID) 28. AIVID 28 is constructed of soft pliable plastic andinclude hard plastic half beads 38 embedded within the soft pliableplastic matrix of AIVID 28. Shown in FIG. 2 at the base of funnelaperture 26 is buoyant bead 30. Extending down vertically from funnelaperture 26 and into IV solution compartment 12 is solution channel 32.IV solution compartment 12 then terminates at its base with an injectionport 34 and a docking port 36 for the IV drip chamber.

IV bag 10 also comprises a pre-cut tab 40 for hanging the IV bag 10, asneeded, and printed measurement markings 42 on the outside of IV bag 10.

Turing now to FIG. 3 and FIG. 4, air column 18 and its features areillustrated in further detail. The IV solution compartment 12 isconnected to AIVID 28 at the base of IV bag 12. AIVID 28 is a small lesspliable plastic component that has a small channel (solution channel 32)through it center that connects it to air column 18 (part of air chamber14). Air column 18 also contains the top of the AIVID 28 which forming afunnel that decreases in size from top to bottom, referred to herein asfunnel aperture 26. Stretching upwards from funnel aperture 26 is a longclear harder plastic tube, as described above, air column 18. Air column18 is designed so that it cannot be easily compressed.

As shown specifically in FIG. 4, the top of air column 18 has a thinmesh, namely mesh network 24, over the top of air column 18, but stillopens into a small compartment, air reservoir 16 where air can bestored. As noted above, air reservoir 16 is comprised of the samepliable material as the IV solution compartment 12.

As shown in FIGS. 9 and 10, the primary purpose of the air reservoir 16is to allow one to visualize the fluid level 52, including the remainingfluid in the IV solution compartment 12 without the risk of inadvertentair administration. As shown in FIGS. 9 and 10, this is accomplishedwith a small blue or red colored buoyant bead 30 that floats on thesurface of the IV solution in solution channel 32.

Turning now to FIGS. 6 and 8, when the buoyant bead is just below thefunnel aperture 26 in AIVID 28, this is considered the closed position.FIGS. 6 and 8 specifically illustrate the details of the “closedposition” of IV bag 10. The “closed position” is required for shippingpurposes. Specifically, when IV bag 10 with buoyant bead 30 is in theclosed position, a barrier is formed effectively blocking the solutionchannel 32 so that IV solution and/or air cannot traverse to oppositesides (enter each other's compartments). This is facilitated by thetight fit of the buoyant bead 30 within the AIVID 28. The “closedposition” may also be referred to as the “locked position.”

Then when the IV bag 10 is hung and ready for use, the medicalprofessional then pinches the AIVID 28, at half beads 38, between hisfingers. The directed pressure of the fingers being squeezed on eachhalf bead 38 in AIVID 28 is sufficient to squeeze the buoyant bead 30from its “closed” or “locked” position. The buoyant bead 30 then risesupwards into funnel aperture 26, as described below with reference toFIGS. 5 and 7.

As shown in FIGS. 5 and 7, the IV bag 10 is now in the “open position.”Once the buoyant bead 30 has been dislodged from the solution channel32, IV solution is allowed to rush upwards filling air column 18. Aircolumn 18 will fill to a level (meniscus 52) corresponding to the levelof the IV solution in IV solution compartment 12. As air column 18 fillswith IV solution, the air in air column 18 is pushed into air reservoir16 through mesh network 24. Mesh network 24 at the top of air column 18serves to keep the buoyant bead 30 from inadvertently entering the airreservoir 16 and becoming trapped.

As noted above in reference to FIGS. 9 and 10, measurement numbers 42and corresponding lines are printed on the outside of IV bag 10 so thatthe medical professional may observe the amount of IV solution beingused. The medical professional can then easily view the amount of IVsolution left by visualizing the buoyant bead 30 on the meniscus 52formed within air column 18 and then comparing that to correspondingmeasurement number 42 printed on the outside of IV bag 10.

As the IV solution is dispensed, the IV solution compartment 12 empties.As the IV solution compartment 12 empties, the fluid level (indicated bymeniscus 52) within the air column 18 also begins to drop. Air from airreservoir 16 then replaces the vacant space left by the droppingmeniscus 52. A particular unique and novel feature of IV bag 10 is thatwhen the IV solution compartment 12 reaches a very low residual volume,the meniscus 52 begins to drop into the funnel aperture 26 of the AIVID28. As this happens, buoyant bead 30 floating on the surface of meniscus52 is slowly aligned to the center by the walls of funnel aperture 26.As the very last amount of IV solution is draining from the IV bag 10,and consequently also from air column 18 through solution channel 32,buoyant bead 30 is guided down atop the opening to solution channel 32.This effectively blocks any air from crossing back through solutionchannel 32 into IV solution compartment 12. In preventing air fromcrossing back into IV solution compartment 12 this consequently alsoprevents air from entering into the IV tubing itself.

Thus, when the IV bag 10 is completely emptied, or “runs dry,” the IVsolution compartment 12 completely collapses forming a small vacuumforce that is transmitted through the solution channel 32 of AIVID 28.This in turn then holds buoyant bead 30 tightly locked in the opening ofsolution channel 32 at the bottom of funnel aperture 26. This in turneffectively blocks any air from passing into intravenous solutioncompartment 12.

When IV bag 10 runs dry, it simply stops dripping. The IV solution fromcompartment 12 and IV tubing in docketing station 36 stop flowing. Theresult is that no air enters the line and another bag can be hungwithout the need for priming the line.

Therefore, this new novel airless intravenous bag system allows amedical professional or other user to accurately measure the amount ofIV fluid given, while reducing the risk of an inadvertent air infusion.Ultimately then, the presently disclosed airless intravenous bag systemreduces or eliminates the potentially life threatening or disablingconsequences of air infusion into a patient via the IV line.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. An airless intravenous bag system, comprising: an intravenous bagincluding an intravenous solution compartment and an air chamberseparated by one or more air tight seams, the air chamber furtherincluding an air column and an air reservoir separated by a meshnetwork; a funnel aperture, wherein the funnel aperture is positionedinside the bottom of the air column and is surrounded by an airlessintravasculature infusion device that is positioned inside the aircolumn; said airless intravasculature infusion device containing twohalf beads positioned at the base of the funnel aperture, the two halfbead capable of being squeezed together; a solution channel extendingfrom the base of the funnel aperture into the IV solution compartment;and a buoyant bead inside the air column, wherein the buoyant bead ispositioned at the base of the funnel aperture when the intravenous bagis transported with intravenous solution in the intravenous solutioncompartment.
 2. The airless intravenous bag system of claim 1, whereinwhen the buoyant bead is positioned at the base of the funnel aperture,a barrier is formed blocking the solution channel so that intravenoussolution cannot traverse into the air chamber.
 3. The airlessintravenous bag system of claim 1, wherein when the buoyant bead ispositioned at the base of the funnel aperture, a barrier is formedblocking the solution channel so that air cannot traverse into theintravenous solution compartment.
 4. The airless intravenous bag systemof claim 1, wherein a user pinches the two half beads together releasingthe buoyant bead from the base of the funnel aperture allowingintravenous solution to flow through the solution channel into the aircolumn.
 5. The airless intravenous bag system of claim 4, wherein theintravenous solution flows through the solution channel filling the aircolumn to the same level as the intravenous solution in the intravenoussolution compartment.
 6. The airless intravenous bag system of claim 4,wherein the intravenous solution forms a meniscus in the air column. 7.The airless intravenous bag system of claim 6, wherein the buoyant beadrises from the base of the funnel aperture to the level of the meniscusin the air column.
 8. The airless intravenous bag system of claim 7,wherein the level of the buoyant bead corresponds to the level of theintravenous solution in the intravenous solution compartment.
 9. Theairless intravenous bag system of claim 1, further including measurementnumbers on the outside of the airless intravenous bag useful fordetermining the amount of intravenous solution in the intravenoussolution compartment.
 10. The airless intravenous bag system of claim 7,wherein the level of the buoyant bead in the air column descends as theintravenous solution in the intravenous solution compartment empties,wherein the level of the buoyant bead is substantially the same level asthe intravenous solution in the intravenous solution compartmentproviding an indicator as to the amount of remaining intravenoussolution in the intravenous solution compartment.
 11. The airlessintravenous bag system of claim 4, wherein air flows through the meshnetwork into the air reservoir as the intravenous solution flows intothe air column.
 12. The airless intravenous bag system of claim 1,further including an injection port at the base of the intravenoussolution compartment.
 13. The airless intravenous bag system of claim 1,further including a docking port at the base of the intravenous solutioncompartment.
 14. The airless intravenous bag system of claim 1, furtherincluding a pre-cut tab for hanging the airless intravenous bag.
 15. Theairless intravenous bag system of claim 1, wherein the level ofintravenous solution in the air column empties through the solutionchannel so that the level of the intravenous solution in the air columnis substantially the same as the level of the intravenous solution inthe intravenous solution compartment.
 16. The airless intravenous bagsystem of claim 15, wherein air from the air reservoir reenters the aircolumn as the intravenous solution in the air column empties through thesolution channel.
 17. The airless intravenous bag system of claim 10,wherein the buoyant bead is aligned in the center of the funnel aperturewhen the intravenous solution reaches a very low level.
 18. The airlessintravenous bag system of claim 17, wherein the buoyant bead returns tothe base of the funnel aperture atop the opening of the solution channelwhen the intravenous solution in the intravenous solution compartment iscompletely emptied, forming a vacuum and preventing air from passinginto the intravenous solution compartment and into an intravenous linethat is connected to the intravenous solution compartment via adocketing port.
 19. An airless intravenous bag system, comprising: anintravenous bag including an intravenous solution compartment and an airchamber separated by one or more air tight seams, the air chamberfurther including an air column and an air reservoir separated by a meshnetwork; a funnel aperture, wherein the funnel aperture is positionedinside the bottom of the air column and is surrounded by an airlessintravasculature infusion device that is positioned inside the aircolumn; said airless intravasculature infusion device containing twohalf beads positioned at the base of the funnel aperture; a solutionchannel extending from the base of the funnel aperture into the IVsolution compartment; and a buoyant bead inside the air column, whereinthe buoyant bead is positioned at the base of the funnel aperture whenthe intravenous solution compartment is empty.
 20. The airlessintravenous bag system of claim 19, wherein the buoyant bead at the baseof the funnel aperture atop the opening of the solution channel forms avacuum preventing air from passing into the intravenous solutioncompartment and into an intravenous line that is connected to theintravenous solution compartment.